EP2441402B1

EP2441402B1 - Implant for stabilizing vertebrae or bones

Info

Publication number: EP2441402B1
Application number: EP12150501.0A
Authority: EP
Inventors: Lutz Biedermann; Wilfried Matthis; Jürgen Harms
Original assignee: Biedermann Technologies GmbH and Co KG
Current assignee: Biedermann Technologies GmbH and Co KG
Priority date: 2007-12-28
Filing date: 2007-12-28
Publication date: 2016-10-26
Anticipated expiration: 2027-12-28
Also published as: US20090204216A1; US8784491B2; TWI498097B; ES2607605T3; TW200927064A; JP5358177B2; EP2441402A1; ES2390482T3; EP2074956A1; JP2009160399A; CN101530343B; EP2074956B1; CN101530343A; US20140288651A1; US9439770B2

Description

The invention relates to an implant for stabilizing vertebrae or bones. In particular, the invention relates to an implant for stabilizing an osteoporotic vertebral body.
A known method for the treatment of vertebral body fractures is the so called vertebroplasty. Bone cement of low viscosity is injected with high pressure directly into the fracture site of the vertebral body. There is a risk that a portion of the bone cement exits the vertebral body and flows into the surrounding area. This may cause discomfort or pain since the bone cement can press onto nerves or the spinal cord. Also, the vascular structure beyond the vertebral end plates can be damaged.
Another method for the treatment of vertebral body fractures is the so-called kyphoplasty. The method consists in first inserting a canula into the broken vertebral body. Then a balloon catheter is inserted into the vertebral body. The balloon is expanded by means of injecting a fluid under X-ray monitoring thereby creating a cavity defined by the balloon catheter volume. Thereafter, the fluid is discharged and the balloon is removed. In a next step bone cement is injected into the cavity. The bone cement can be a bone cement with high viscosity compared to that used in vertebroplasty. Although the risk of bone cement escaping into the surrounding is lower than in vertebroplasty, the risk is still non-neglectable. Also due to the size of the cavity the amount of bone cement used is substantial.
Both of these methods can also be applied to weak and partly collapsed osteoporotic vertebrae.
A problem which is common to vertebroplasty and kyphoplasty is that the vertebral bodies become completely stiffened which enhances the likelihood of a fracture of the neighbouring vertebral bodies due to overloading.
Document WO 2007/078692 A2 discloses an expandable cage comprising a proximal ring, a distal ring and a plurality of elongate members fixedly attached to the rings. The cage can be inserted into a vertebral body and expanded therein. A delivery tube is removably attached to the cage via threaded or frictional engagement.
Document US 2006/0100706 A1 discloses an expandable stent comprising struts in a zig-zag configuration. The cage can be inserted into a vertebral body and expanded therein. A introducer having an elongate shaft carries the stent.
Document US 2007/0016200 A1 discloses a connecting member which connects severable poly-axial bone screw assemblies which are anchored in vertebral bodies, respectively. The connecting member comprises two cylindrical segments which are connected via a cage-like structure such as to for a dynamic stabilization device. The cage-like structure consists of each one planar side extending perpendicular to a respective one of the segments. The two sides are connected via U-shaped segments, wherein two slits are formed in each segments which terminate in a central portion of each U-shaped segment. The central portion provides an area of additional strength when the segment bends due to compressive forces acting on the connecting member.
It is the object of the invention to provide an implant for the stabilization of vertebrae or bones which overcomes the above mentioned problems.
The object is solved by an implant according to claim 1. Further developments are given in the dependent claims.
The implant according to the invention can be used without bone cement. Therefore, there is no risk of damaging the vascular structure beyond the vertebral end plate. The long-term outcome of the treatment is improved. The implant forms an internal flexible support of the end plate which reduces the risk of a fracture of neighbouring vertebrae.
Further features and advantages of the invention will become apparent from the detailed description of embodiments referring to the accompanying drawings.
In the drawings:

Fig. 1 shows a perspective view of an embodiment of the implant in a state in which it can be inserted. This embodiment does not fall within the scope of the claims.
Fig. 2 shows a perspective view of the implant of Fig. 1 in an expanded state.
Fig. 3 shows a modified embodiment of the implant in an expanded state. This embodiment does not fall within the scope of the claims.
Fig. 4 shows a perspective view of the implant of Fig. 1 abutting against a stop before it is expanded.
Fig. 5 shows the step of expanding the implant of Fig. 4.
Fig. 6 shows a second embodiment of the implant abutting against a stop before it is expanded. This is the only embodiment falling within the scope of the claims.
Fig. 7 shows the implant of Fig. 6 when it is expanded.
Figs. 8 show steps of inserting the implant into the to 11 vertebral body and expanding it.
Fig. 12 shows two implants inserted and expanded.
Fig. 13 shows a side view of a third embodiment of the implant used together with a pedicle bushing. This embodiment does not fall within the scope of the claims.
Fig. 14 shows the implant of Fig. 13 in a partially sectional view.
Fig. 15 shows a schematic sectional view of a vertebral body with a pedicle bushing and an implant according to Figs. 13 and 14.
Fig. 16 shows an example of a further application of the implant.
Fig. 17 shows an example of a still further application of the implant.

A first embodiment of the implant is described with reference to Figs. 1 and 2. The implant 1 is tubular with a longitudinal axis L and comprises a first end section 2 and a second end section 3 and an intermediate section 4. The intermediate section 4 consists of a plurality of longitudinal strips 5 extending from the first end section 2 to the second end section 3. There are gaps or slots 6 between the longitudinal strips 5 which also extend from the first end section 2 to the second end section 3. Pairs of longitudinal strips 5 are connected to each other approximately at their center when seen in the longitudinal direction via a transverse strip 7, respectively. Hence, two longitudinal strips 5 and the connecting transverse strip 7 form a strip unit 8. As can be seen, every second of the slots 6 extends further into the tubular end sections 2 and 3. The strips 5 provide flexibility to the intermediate section 4 in such a manner that as shown in Fig. 2, the intermediate section 4 can be expanded like a balloon by outward bending of the strip units 8 thereby widening the slots 6 between the strip units 8. The dimension of the implant is such that it can be inserted through a hole formed in the pedicle of a vertebra into the vertical body. In particular, the length of the intermediate section 4 is selected such that in an expanded state as shown in Fig. 2 the intermediate section 4 can be accommodated in a vertebral body. The number of longitudinal and transverse strips, their shape, their distance and their thickness are selected so as to provide the desired elasticity and desired dimensions to the expanded implant.
The implant can be made of biocompatible material, in particular of a biocompatible metal such as titanium or a biocompatible plastics such as PEEK (polyaryletheretherketone). Particularly suitable are materials such as shape memory alloys exhibiting shape memory properties and/or superelasticity. One example of a suitable material is a nickel titanium alloy such as nitinol.
The implant can be made from a tube where the intermediate section 4 is produced by cutting slots into the tube to create the strips, for example by means of laser cutting.
As can be seen in Figs. 1 and 2, the first end section 2 is shorter than the second end section 3 and the first end section 2 can have a closed end (not shown). The first end section 2 is used as the proximal end section which is introduced first into the vertebral body whereas the second end section 3 can be adapted for engagement with a tool or with further implant parts.
Fig. 3 shows a perspective view of a modified embodiment 1' of the implant which differs from the implant 1 shown in Figs. 1 and 2 by the shape of the expanded intermediate section 4'. The other parts are identical and therefore, the description thereof is not repeated. While the intermediate section 4 shown in Fig. 2 has approximately a spherical or ellipsoidal shape, the intermediate section 4' of the implant 1' in Fig. 3 comprises flat portions 5a' of strips 5' extending in parallel to the longitudinal axis L. The strips 5' are shaped in such a way that when expanding the intermediate section 4' it forms an approximately polygonal shape which tapers towards the first end section 2 and to the second end section 3.
It should be noted that any desired shape of the expanded intermediate section 4 can be achieved by designing the pattern of longitudinal and transverse strips in a suitable manner. For example, it is possible to design the intermediate section 4 as a pattern of wires extending from the first end section 2 to the second end section 3 and being connected by welding or by intermediate transverse wires in an open mesh-like manner. The flexibility is generated by providing gaps which allow expansion of the intermediate section 4 in a radial direction when the implant is compressed in an axial direction. The intermediate section 4 can also be pre-expanded to some extent. Due to its flexibility, the pre-expanded intermediate section is compressible in a radial direction.
The function of the implant is explained with reference to Figs. 4 and 5. The implant 1 shown in Figs. 4 and 5 has two adjacent transverse strips 7 which form one broad transverse strip. However, as described above, any shape of the strips and pattern of the transverse and longitudinal strips can be achieved by a specific shape and specific dimensions of the strips. Fig. 4 shows the implant 1 with the intermediate section 4 in a non-expanded state. The implant 1 has a length l₁ between the outermost end of the first end section 2 and the outermost end of the second end section 3 and a diameter d₁ at the center of the intermediate portion 4. The implant 1 abuts against a stop or an abutment 9 with the first end section 2. The abutment is, for example, an inner wall portion of the vertebral body. When a force F is exerted in an axial direction to press the implant 1 with the first end section 2 against the abutment 9 as shown in Fig. 5, the intermediate section 4 expands like a balloon and assumes a shape which in this embodiment is roughly spherical or ellipsoidal. In this expanded state the implant has a length l₂ which is smaller than l₁ and a diameter d₂ which is larger than diameter d₁ in the non-expanded state. Hence, the intermediate section 4 is flexible in such a manner that it is expandable in a radial direction when a force acts in an axial direction which reduces the distance between the first end section 2, and the second end section 3.
A second embodiment 10 of the implant is shown in Figs. 6 and 7. Portions which are identical to the previous embodiments are indicated with the same reference numerals and the description thereof is not repeated. The implant 10 differs from the implant according to the previous embodiments in that it comprises a tension element 11 which is provided inside the tubular implant and which is connected to one end, in the embodiment shown it is connected to the first end section 2. It extends through the intermediate section 4 and the second end section 3 to the outside. At its end opposite to the first end section 2 the tension element 11 comprises an end portion 12 which can be shaped so as to facilitate gripping. The diameter of the end portion 12 can be larger than the diameter of the second end section 3 so that the end portion 12 forms a stop with respect to the second end section 3. The tension element 11 can be, for example, a rod or a wire. It can be made of any biocompatible material. The function of the implant 10 according to the second embodiment is different from that of the previous embodiments in that the stop 9' has to be provided at the second end portion 3. When a force F' is applied in axial direction pulling the tension element 11 away from stop 9', the implant 10 is compressed in an axial direction from a length l₁ to a smaller length l₂ while the intermediate section 4 expands from a diameter d₁ to a larger diameter d₂.
The second embodiment is useful for such cases where it is not possible to provide a stop at the proximal first end section 2.
Use of the implant is now explained with reference to Figs. 8 to 11. Figs 8 to 10 show schematic views of a vertebra 100 from the top and Fig. 11 from the side. The vertebral body 101 is damaged (not shown), for example, by osteoporosis or by a fracture. First, as shown in Fig. 8 a hole 102 is prepared in the pedicle of vertebra 100, the hole reaching the damaged inner vertebral body 101. The implant 1 is inserted into the hole and, as shown in Fig. 9, pushed into the vertebral body 101 until the end section 2 abuts against the inner wall, which forms a stop 9 for the implant. When pushing the implant 1 against stop 9 the intermediate section 4 expands into the vertebral body. As can be seen in Fig. 11 the expanded implant which is compressible to some extent in the region of its intermediate section 4 forms a flexible support for the end plate 103 thereby approximating the elastic properties of the vertebral body. By means of this an overstressing of neighbouring vertebrae which can result in a fracture of neighbouring vertebrae can be reduced.
The implant 1 can be held in place by closing the hole, for example with a closure screw (not shown) which can be screwed into the hole 102 and which presses onto the second end section 3.
As shown in Fig. 10, the intermediate section 4 is fully expanded. However, the intermediate section can also be expanded only partially. This may be the case when the intermediate section is not fully introduced into the vertebral body and a part of the intermediate section 4 is constrained by the surrounding wall of the hole 102.
As shown in Fig. 12 two implants can be used in a single vertebra which are inserted from the left and the right pedicle, respectively. This provides a more symmetric stabilization. It remains the choice of the surgeon to use one or two implants according to the clinical situation.
Figs. 13 to 15 show a third embodiment of the implant. The implant 20 differs from the previously described embodiments by the structure of the second end section. Other parts of the implant 20 which are identical to those of the previous embodiments are designated with the same reference numerals and the description thereof is not repeated. The implant 20 comprises an end section 3' which is prolonged compared to the end section 3 of the implant of the previous embodiments. The second end section 3' comprises a portion 21 with an outer thread which is preferably provided at the end facing away from the intermediate section 4. The outer thread can be a metric thread. The length of the second end section is such that in the inserted state shown in Fig. 15 the second end section 3' extends through the pedicle area.
The implant further comprises a bushing 22 provided with a bone thread for engaging the inner wall of the hole 102. Instead of a bone thread, the outer diameter of the bushing 22 can be slightly oversized with respect to the diameter of the hole 102 such that a press-fit connection is formed between the pedicle hole and the bushing or it can be roughened so that it is held in the hole 102 by friction. The bushing 22 further comprises at one end a portion 23 with an inner thread which cooperates with the outer thread of the portion 21 of the second end section 3' of the implant. The length of the bushing is approximately the same as that of the pedicle hole 102. The bushing is oriented in the pedicle hole 102 in such a manner that the portion 23 with the inner thread is directed away from the center of the vertebral body 101.
In use, first, the bushing 22 is inserted into the hole 102 then the implant 20 is guided through the bushing 22 until the treaded portions 21 and 23 of the implant and the bushing, respectively, come into engagement. By further screwing the implant into the bushing until the first end section abuts against the inner wall of the vertebral body the intermediate section 4 is expanded to fill out a portion of the vertebral body. The expanded implant forms a flexible support which stabilizes the vertebral body without the necessity of using bone cement.
Also with respect to this embodiment modifications are possible. The second end section 3' can be made of two pieces wherein the portion comprising the outer thread is made as a separate piece which is connectable to the implant. The intermediate section 4 can be rotatably fixed to the second end section 3' in such a way that by screwing in the second end section 3' only an axial force is generated with respect to the intermediate section, i.e. the intermediate section 4 does not rotate while advancing into the vertebral body. The end sections need not to be tubular and they can have any other cross section instead of a circular cross section. They can also be curved instead of being linear.
Other means for connecting the implant and the bushing are also conceivable, for example, a press-fit connection.
Moreover, the present disclosure also encompasses an aspect (not shown) in which the implant 1 comprises the bushing 22 provided for guiding the implant to the implantation site and coincidently the tension element 11, which, when it is actuated, shortens the length of the tubular section 4.
It is also possible to connect the implant to further implant parts such as screw heads which connect spinal rods or other parts to the vertebrae. Fig. 16 shows a schemativ top view of the vertebra 100 with two implants 20' and 20" and corresponding bushings 22', 22". One implant 20' is connected with its second end section 3' monoaxially to a receiving part 24 accomodating a spinal rod 104 secured by a screw. The other implant 20" is connected with its end section 3" polyaxially to a receiving part 25 accomodating a rod 104' secured by a screw.
An additional clinical use of the implants may be the support of weak or fractured bone structures in long bones like the femoral head section, the tibia plateau and other bone areas. Fig. 17 shows the application of the implant 200 to support the femoral head 201. The second end section 203 of the implant 200 is connected to a bone screw 204 which itself can be connected to a marrow nail 205. Further screws 206 can be provided as usual.

Claims

Implant for use in stabilizing vertebral bodies or bones, comprising
a first end section (2) and
a second end section (3, 3'),
a tubular section (4, 4') between the first end section (2) and the second end section (3,3') having a longitudinal axis (L),
the tubular section (4) being flexible in such a way that it is expandable in a radial direction when a force (F, F') acts in the axial direction which reduces the distance between the first end section (2) and the second end section (3),
the tubular section (4, 4') being formed of a plurality of longitudinal strips (5) extending from the first end section (2) to the second end section (3) and which are connected at their ends, respectively, to the first end and the second end, wherein pairs of longitudinal strips (5) are connected to each other approximately at their centre when seen in the longitudinal direction via a transverse strip (7),
wherein: the implant further comprises a tension element (11), which, when it is actuated, shortens the length of the tubular section (4, 4'),
characterised in that
the tension element (11) is connected to the first end section (2) and extends through the tubular section (4, 4') and the second end section (3, 3') to the outside.
The implant according to claim 1, wherein at least the tubular section (4) is made of a shape memory alloy exhibiting superelasticity.
The implant to claim 1 or 2, wherein at least one of the end sections (2, 3) is tubular.
The implant according to one of claims 1 to 3, wherein a bushing (22) is provided for guiding the implant to the implantation site.
The implant according to claim 4, wherein the bushing (22) comprises an engagement structure (23) for engagement with the engagement structure (21) of the first or the second end section.
The implant according to claim 5, wherein the engagement structure (21, 23) is a thread.
The implant according to one of claims 4 to 6, wherein the bushing (22) comprises an outer thread, preferably a bone thread.
The implant according to one of claims 1 to 7, wherein the tubular section comprising longitudinal slots (6) extending from the first end section (2) to the second end section (3) between the longitudinal strips (5, 5').